DuraSeal Exact Spinal Sealant
FDA premarket approval P080013/S025 · decided 2023-02-16
Approval details
- PMA number
- P080013
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DuraSeal Exact Spinal Sealant
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2023-01-17
- Decision date
- 2023-02-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Changing the test method from the oxidizable substances test to the total organic carbon test for the water for injection and changing the high-performance liquid chromatography test method to determine the purity of trilysine
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